K Number

Device Name

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

Manufacturer

BAYER CORP.

Date Cleared

1999-09-15

(58 days)

Product Code

CIX CEM CEO CGZ CHH CHS CIG JGS KXT

Regulation Number

862.1035

Intended Use

The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney. The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders. The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy. The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance. The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.

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Predicate Devices

Technicon CHEM 1 Albumin, Technicon CHEM 1 T.Bilirubin, Technicon CHEM 1 Carbon Dioxide, Enzymatic, Bayer Immuno 1 Digoxin, Bayer Technicon Chem 1 HDL cholesterol method, Technicon CHEM 1® Inorganic Phosphorus

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard in vitro diagnostic assays and their performance characteristics, with no mention of AI or ML technologies.

Therapeutic

No
This device is an in vitro diagnostic device used to measure various analytes in human samples for diagnostic, monitoring, and treatment purposes, not to provide therapy itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic device" for all listed assays, and that the measurements are "used in the diagnosis, monitoring and treatment of a variety of diseases".

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic device intended to measure various analytes in human serum or plasma. This requires physical interaction with biological samples and likely involves hardware components for sample handling, analysis, and measurement, which are not described as being solely software. The performance studies also refer to "comparison systems" and "comparison methods" which are likely other physical laboratory instruments.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states for each assay that it is an "in vitro diagnostic device intended to measure..." various analytes in human serum, plasma, or urine. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.

The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy.

The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance.

The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.

Product codes (comma separated list FDA assigned to the subject device)

CIX, CIG, CHS, KXT, CHH, CEO, JGS, CEM, CGZ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Albumin:
Imprecision(SERUM):
ADVIA IMS: Level (g/dL) 2.1, Total CV(%) 1.9; Level (g/dL) 3.4, Total CV(%) 1.6; Level (g/dL) 4.9, Total CV(%) 1.5.

Correlation (Y=ADVIA IMS, X=comparison system):
Specimen type Serum, Comparison System (X) CHEM 1+, N 53, Regression Equation Y=1.01X+0.55, Syx (g/dL) 0.13, r 0.990, Sample Range (g/dL) 1.4 - 5.3.
Specimen type Plasma(y), Serum(x), Comparison System (X) ADVIA IMS, N 59, Regression Equation Y=0.96X+0.12, Syx (g/dL) 0.06, r 0.978, Sample Range (g/dL) 3.9 - 5.2.

Interfering Substances:
U. Bilirubin (25 mg/dL) at 4.2 g/dL Albumin Conc. had -4.8 % change.
Hemoglobin (1000 mg/dL) at 3.5 g/dL Albumin Conc. had +5.7 % change.
Lipids (Triglycerides) (1000 mg/dL) at 3.5 g/dL Albumin Conc. had -2.9 % change.

Analytical Range: Scrum/Plasma: 1 to 6 g/dL.

T.Bilirubin:
Imprecision(SERUM):
ADVIA IMS: Level (mg/dL) 1.1, Total CV(%) 7.0; Level (mg/dL) 4.5, Total CV(%) 5.1; Level (mg/dL) 17.0, Total CV(%) 2.4.
CHEM 1: Level (mg/dL) 1.1, Total CV(%) 9.1; Level (mg/dL) 5.0, Total CV(%) 4.8; Level (mg/dL) 20.0, Total CV(%) 2.6.

Correlation (Y=ADVIA IMS, X=comparison system):
Specimen type Serum, Comparison System (X) CHEM 1+, N 58, Regression Equation Y=1.08X-0.11, Syx (mg/dL) 0.26, r 0.998, Sample Range (mg/dL) 0.2 - 26.1.
Specimen type Plasma(y), Serum(x), Comparison System (X) ADVIA IMS, N 57, Regression Equation Y=1.01X-0.01, Syx (mg/dL) 0.02, r 0.994, Sample Range (mg/dL) 0.16 - 0.92.

Interfering Substances:
Hemoglobin (500 mg/dL) at 6.9 mg/dL T.Bilirubin Conc. had +1 % change.
Lipids (Triglycerides) (500 mg/dL) at 6.7 mg/dL T.Bilirubin Conc. had -34 % change.

Analytical Range: Serum/Plasma: 0 to 45 mg/dL.

CO2:
Analytical Range: 10 to 40 mEq/L (for both ADVIA IMS and CHEM 1).

Precision (Total):
ADVIA IMS: 5.3% @ 11.98 mEq/L; 4.3% @ 19.10 mEq/L; 3.0% @ 28.39 mEq/L.
CHEM 1: 4.5% @ 14 mEq/L; 3.8% @ 22 mEq/L; 3.3% @ 28 mEq/L.

Correlation:
Regression Equation: Y=0.99X+0.41 mEq/L Where Y=ADVIA IMS, X=CHEM 1, N=106 (53 pairs).
r=0.993, Sy.x=0.999 mEq/L.

Interfering Substances:
Bilirubin (unconjugated) 25 mg/dL: -2.0% effect change @ 27.84 mEq/L CO2.
Bilirubin (conjugated) 25 mg/dL: -37% effect change @ 28.83 mEq/L CO2.
Hemoglobin (hemolysate) 500 mg/dL: -10.0% effect change @ 28.67 mEq/L CO2.
Lipemia (Triglycerides) 500 mg/dL: No effect change mentioned.

Digoxin:
Imprecision:
ADVIA IMS: Level (ng/mL) 0.82, Total CV (%) 6.8; Level (ng/mL) 1.80, Total CV (%) -5.1; Level (ng/mL) 3.81, Total CV (%) 4.8.
Immuno 1: Level (ng/mL) 0.7, Total CV (%) 8.2; Level (ng/mL) 2.2, Total CV (%) 4.2; Level (ng/mL) 3.4, Total CV (%) 3.6.

Correlation (Y=ADVIA IMS, X=Comparison system):
Specimen type Serum, Comparison System (X) Immuno 1, N 63, Regression Equation Y=0.93X - 0.11, Syx (ng/mL) 0.17, R 0.98, Sample Range (ng/mL) 0.15-3.90.

Interfering Substances:
Bilirubin (25 mg/dL) at 2 ng/mL Digoxin Conc. had 3.9 % change.
Bilirubin (unconjugated) (25 mg/dL) at 2 ng/mL Digoxin Conc. had -3.9 % change.
Hemoglobin (500 mg/dL) at 2 ng/mL Digoxin Conc. had -0.3 % change.
Lipids (Triglycerides) (500 mg/dL) at 2 ng/mL Digoxin Conc. had -11.7 % change.

Analytical Range: 0.1-5.0 ng/mL.
Minimum Detectable Concentration: 0.1 ng/mL.

HDL cholesterol:
Analytical Range: ADVIA IMS: 0 to 250 mg/dL; CHEM 1: 10 to 100 mg/dL.

Precision (Total):
ADVIA IMS: Level 1 Mean (mg/dL) 18, % CV 3.2; Level 2 Mean (mg/dL) 42, % CV 2.6; Level 3 Mean (mg/dL) 121, % CV 2.8.
CHEM 1: Mean (mg/dL) 20, % CV 8.5; Mean (mg/dL) 46, % CV 6.7; Mean (mg/dL) 58, % CV 4.8.

Correlation to existing system:
Regression Equation: y = 0.997x + 1.95, where y = ADVIA IMS, x = Chem 1, n = 107 (54 samples in duplicate), r = 0.987, Sy.x = 3.58, range = 19 to 123 mg/dL.

Plasma Qualification:
Regression Equation: y=0.995X +0.12, where y = plasma, x = serum, n = 90 (47 samples in duplicate), r = 0.996, Sy.x = 1.3, range = 18 to 71 mg/dL.

Interference:
Hemoglobin (250 mg/dL) at 47.2 mg/dL HDL cholesterol Conc. had -19 % Change.
Bilirubin (conjugated) (6.25 mg/dL) at 45.2 mg/dL HDL cholesterol Conc. had -27 % Change.
Bilirubin (unconjugated) (25 mg/dL) at 43.1 mg/dL HDL cholesterol Conc. had -2 % Change.
Lipemia (Triglycerides) (1000 mg/dL) at 44.3 mg/dL HDL cholesterol Conc. had +1 % Change.

Inorganic Phosphorus:
Imprecision(SERUM):
ADVIA IMS: Level (mg/dL) 2.5, Total CV(%) 1.7; Level (mg/dL) 5.0, Total CV(%) 2.1; Level (mg/dL) 8.8, Total CV(%) 2.7.
CHEM 1: Level (mg/dL) 3.1, Total CV(%) 3.4; Level (mg/dL) 6.6, Total CV(%) 2.7; Level (mg/dL) 7.7, Total CV(%) 2.8.

Imprecision(URINE):
ADVIA IMS: Level (mg/dL) 24.8, Total CV(%) 1.9; Level (mg/dL) 69.8, Total CV(%) 2.2; Level (mg/dL) 96.3, Total CV(%) 1.9.
CHEM 1: Level (mg/dL) 37, Total CV(%) 2.6; Level (mg/dL) 55, Total CV(%) 2.7.

Correlation (Y=ADVIA IMS, X=comparison system):
Specimen type Serum, Comparison System (X) CHEM 1+, N 50, Regression Equation Y = 0.94X + 0.15, Syx (mg/dL) 0.15, r 0.997, Sample Range (mg/dL) 1.3 - 10.0 mg/dL.
Specimen type Plasma(y), Serum(x), Comparison System (X) ADVIA IMS, N 58, Regression Equation Y=0.96X-0.17, Syx (mg/dL) 0.12, r 0.977, Sample Range (mg/dL) 1.9-4.4 mg/dL.
Specimen type Urine, Comparison System (X) CHEM 1, N 48, Regression Equation Y = 1.01X + 0.15, Syx (mg/dL) 1.17, r 0.999, Sample Range (mg/dL) 4.5 - 99.9 mg/dL.

Interfering Substances:
Bilirubin (20 mg/dL) at 3.7 mg/dL Inorganic Phosphorus Conc. had +2.2 % change.
Hemoglobin (500 mg/dL) at 3.6 mg/dL Inorganic Phosphorus Conc. had +19.4 % change.
Lipids (Triglycerides) (500 mg/dL) at 3.8 mg/dL Inorganic Phosphorus Conc. had +21.6 % change.
Acetaminophen (50 mg/dL) at 8.0 mg/dL Inorganic Phosphorus Conc. had -3.8 % change.
Ascorbic Acid (200 mg/dL) at 18.4 mg/dL Inorganic Phosphorus Conc. had +1.3 % change.
Salicylate (500 mg/dL) at 18.4 mg/dL Inorganic Phosphorus Conc. had +5.0 % change.

Analytical Range: Serum/Plasma: 0 to 15 mg/dL; Urine: 0 to 100 mg/dL.

Sodium, Potassium, and Chloride:
Imprecision:
Sodium: Level (mmol/L) 113, Total CV(%) 1.0; Level (mmol/L) 139, Total CV(%) 1.0.
Potassium: Level (mmol/L) 3.4, Total CV(%) 1.3; Level (mmol/L) 5.9, Total CV(%) 1.2.
Chloride: Level (mmol/L) 93, Total CV(%) 1.2; Level (mmol/L) 113, Total CV(%) 1.2.

Correlation (Y=ADVIA IMS, X=comparison system):
Sodium (Serum): Comparison System (X) IL Flame, N 53, Regression Equation 0.94 x Flame + 7.08 mmol/L, Syx (mmol/L) 1.68, R 0.957, Sample Range (mmol/L) 120.0-147.1.
Potassium (Serum): Comparison System (X) IL Flame, N 54, Regression Equation 1.03 x Flame - 0.15 mmol/L, Syx (mmol/L) 0.17, R 0.990, Sample Range (mmol/L) 2.55-8.72.
Chloride (Serum): Comparison System (X) Chloridometer, N 51, Regression Equation 0.84 x Chloridometer + 16.0 mmol/L, Syx (mmol/L) 1.1, R 0.986, Sample Range (mmol/L) 83.6-115.5.

Plasma/Serum Comparison:
Sodium: Mean Serum Level 137.2, Mean Plasma Level 137.2, Mean Difference 0.0, % Difference 0.0.
Potassium: Mean Serum Level 3.97, Mean Plasma Level 3.76, Mean Difference 0.21, % Difference 5.6.
Chloride: Mean Serum Level 105.2, Mean Plasma Level 105.2, Mean Difference 0.0, % Difference 0.0.

Interfering Substances:
Sodium: No significant effect on serum has been demonstrated from bromide, ammonium and iodide.
Potassium: Since the concentration of potassium inside erythrocytes is much greater than that in extracellular fluid, hemolysis should be avoided, and the serum/plasma should be separated from the cells as soon as possible after collection.
Chloride: Sodium Salicylate at a level of 2.2 mmol/L (30 mg/dL) will elevate the chloride result by less than 2.0 mmol/L. The presence of bromide or iodide salts will falsely elevate chloride results.

Analytical Range: Serum or Plasma: Sodium 40 to 205 mmol/L; Potassium 1.5 to 15 mmol/L; Chloride 50 to 200 mmol/L.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.

Summary

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Albumin method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K992396

1. Intended Use

This in vitro diagnostic method is intended to measure albumin in human serum or plasma on the Baver ADVIA IMS system. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidneys.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1 Albumin	T01-1458-53	T03-1291-62

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IM Albumin	B41-3717-26	T03-1291-62

A. Imprecision(SERUM)

ADVIA IMS
Level (g/dL)	Total CV(%)
2.1	1.9
3.4	1.6
4.9	1.5

Correlation (Y=ADVLA IMS. X=comparison system) 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Specimen type	Comparison System (X)	N	Regression Equation	Syx (g/dL)	r	Sample Range (g/dL)
Serum	CHEM 1+	53	Y=1.01X+0.55	0.13	0.990	1.4 - 5.3
Plasma(y), Serum(x)	ADVIA IMS	59	Y=0.96X+0.12	0.06	0.978	3.9 - 5.2

Interfering Substances

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Albumin Conc.
(g/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|-------------------------|----------------------|
| U. Bilirubin | 25 | 4.2 | -4.8 |
| Hemoglobin | 1000 | 3.5 | +5.7 |
| Lipids (Triglycerides) | 1000 | 3.5 | -2.9 |

Analytical Range

Scrum/Plasma: 1 10 6 g/dL

7/16/99

Gabriel J. Murray, Jr.

Manager Reg Affairs.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS T.Bilirubin method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Intended Use

This in vitro method is intended to quantitatively measure total bilirubin in human serum and plasma on the Bayer ADVIA IMS systems. Measurements of total bilirubin are used in the diagnosis and treatment of liver, bemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.

2. Predicate Device

| Product Name | would be and the country of the country of the country of the country of the country of the country of the country of the country of the country of the country of the country
Reagent Part # Calibrator Part #
for and and the program and and the many of the many of the many of the many of the many of the may be the may be the may be the may be the may be the may be the may be the b |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technicon CHEM 1 T.Bilirubin T01-1522-53 T03-1291-62 | |

3. Device / Method

Product Name		Reagent Part # Calibrator Part #
www.rangestion.com/production/compress/from the managements of the comments of the comments of the comments of the comments of the comments of the comments of the comments of
ADVIA IMS T.Bilirubin	B41-3723-46 T03-1291-62	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Imprecision(SERUM)

ADVIA IMS	CHEM 1
Level
(mg/dL)	Total
CV(%)	Level
(mg/dL)	Total
CV(%)
1.1	7.0	1.1	9.1
4.5	5.1	5.0	4.8
17.0	2.4	20.0	2.6

Correlation (Y=ADVIA IMS, X=comparison system)

| Specimen type | Comparison
System (X) | N | Regression Equation | Syx
(mg/dL) | r | Sample Range
(mg/dL) |
|---------------------|--------------------------|----|---------------------|----------------|-------|-------------------------|
| Serum | CHEM 1+ | 58 | Y=1.08X-0.11 | 0.26 | 0.998 | 0.2 - 26.1 |
| Plasma(y), Serum(x) | ADVIA IMS | 57 | Y=1.01X-0.01 | 0.02 | 0.994 | 0.16 - 0.92 |

Interfering Substances

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | T.Bilirubin
Conc. (mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|------------------------------|----------------------|
| Hemoglobin | 500 | 6.9 | +1 |
| Lipids (Triglycerides) | 500 | 6.7 | -34 |

Gabriel J. Murray Jr.
Manager Reg. Affairs

Analytical Range

Serum/Plasma: 0 to 45 mg/dL

SUMMARY OF SAFETY AND EFFECTIVENESS

CO2 Method for the Bayer ADVIA Integrated Modular System (IMS)

Listed below is a comparison of the performance between the Bayer ADVIA IMS CO2 method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Carbon Dioxide, Enzymatic). The information used in the Summary of Safety and Effectiveness was extracted from the Bayer ADVIA IMS CO2 method sheet and the CHEM 1 CO2 (Enzymztic) method sheet.

INTENDED USE

This in-vitro diagnostic method is intended to measure carbon dioxide (CO2) in human serum. Measurement of CO, is used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

METHOD		ADVIA IMS	CHEM 1
Part No.	Reagents	B41-3726-43	T01-3253-53
	Calibrators/
CO2 diluent	T03-1291-62/
T23-1291-52	T01-1291-62/
T23-1291-52
Analytical Range		10 to 40 mEq/L	10 to 40 mEq/L
Precision (Total)		5.3% @ 11.98 mEq/L
4.3% @ 19.10 mEq/L
3.0% @ 28.39 mEq/L	4.5% @ 14 mEq/L
3.8% @ 22 mEq/L
3.3% @ 28 mEq/L
Correlation		Y=0.99X+0.41 mEq/L
Where
Y=ADVIA IMS
X=CHEM 1
N=106 (53 pairs)	7/16/99
Gabriel J. Mno

r=0.993

Sy.x=0.999 mEq/L

Interfering Substances

Bilirubin (unconjugated) 25 mg/dL Bilirubin (conjugated) 25 mg/dL Hemoglobin (hemolysate) 500 mg/dL Lipemia (Triglycerides) 500 mg/dL

-2.0% effect change @ 27.84 mEq/L CO2 -37% effect change @ 28.83 mEq/L CO2 -10.0% effect change @ 28.67 mEq/L CO2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Digoxin Method for ADVIA IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: (leave blank)

1. Intended Use

This in vitro method is intended to quantitatively measure digoxin in human serum on the Bayer ADVIA IMS systems. Measurements of digoxin are used to aid in attaining optimum therapy in patients treated with the drug.

Predicate Device 2.

Product Name	Reagent Part #	Calibrator Part #
Bayer Immuno 1 Digoxin	T01-2875-51	T01-2864-01

Device / Method 3.

Name
----------------------------------------------------------------------
AMC T
unxoxobili
the call a the collection of the consideration of the are of	A 40 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1	11

A. Imprecision

ADVIA IMS		Immuno 1
Level
(ng/mL)	Total
CV (%)	Level
(ng/mL)	Total
CV (%)
0.82	6.8	0.7	8.2
1.80	-5.1	2.2	4.2
3.81	4.8	3.4	3.6

B. Correlation (Y=ADVIA IMS, X=Comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (ng/mL)	R	Sample Range (ng/mL)
Serum	Immuno 1	63	$Y=0.93X - 0.11$	0.17	0.98	0.15-3.90

7/14/99 Gabriel J. Murray Jr. - Manager Reg. Affairs

C. Interfering Substances
Interfering
Substance	Interfering Sub.
Conc. (mg/dL)	Digoxin Conc.
(ng/mL)	Effect
(% change)
Bilirubin	25	2	3.9
Bilirubin
(unconjugated)	25	2	-3.9
Hemoglobin	500	2	-0.3
Lipids
(Triglycerides)	500	2	-11.7

2011

. ..........

. . . . . . . . . . . . . . . .

. . . . .

: · ·

Analytical Range: 0.1-5.0 ng/mL Minimum Detectable Concentration: 0.1 ng/mL

Date 7/16/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. M. Gabriel J. Muraca, Jr. Manager Regulatory Affairs

914-524-3494 (fax 914-524-2500)

SUMMARY OF SAFETY AND EFFECTIVENESS

HDL cholesterol Method for the ADVIA IMS Systems

Listed below is a comparison of the performance of the Bayer ADVIA HDL cholesterol method and a similar device that was granted clearance of substantial equivalence (Bayer Technicon Chem 1 HDL cholesterol method). The information was extracted from the Baver ADVIA IMS HDL cholesterol method sheet.

INTENDED USE

The Bayer ADVIA IMS HDL cholesterol assay is an in-vitro diagnostic device intended to measure HDL cholesterol in human serum and plasma. Such measurements are used in the diagnosis, monitoring and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This diagnostic method is not intended for use on any other diagnostic system.

SERUM

| HDL CHOLESTEROL

METHOD:	ADVIA IMS	CHEM 1
Part Number:	Cholesterol Reagent
B41-3727-46
HDL precipitating reagent
B21-3733-01
Calibrators T03-1291-62	cholesterol reagent
T01-2869-01
HDL Precipitating reagent
T01-1897-56
Calibrators T03-1291-62
Analytical Range:	0 to 250 mg/dL	10 to 100 mg/dL
Precision (Total):	Mean (mg/dL)	% CV
Level 1	18	3.2
Level 2	42	2.6
Level 3	121	2.8
	mean (mg/dL)	% CV
	20	8.5
	46	6.7
	58	4.8

Correlation to existing system
Regression Equation: y = 0.997x + 1.95
where:	y = ADVIA IMS
	x = Chem 1
	n = 107 (54 samples in duplicate)
	r = 0.987
	Sy.x = 3.58
	range = 19 to 123 mg/dL

7/16/94 Gabriel J. Muraca Jr. - Muraca By. Affairs.

Plasma Qualification
Regression Equation: y=0.995X +0.12
where:	y	= plasma
	x	= serum
	n	= 90 (47 samples in duplicate)
	r	= 0.996
	Sy.x	= 1.3
	range	= 18 to 71 mg/dL

Interference

| | Interfering Substance
Concentration | HDL
cholesterol
Concentration | Effect
% Change |
|--------------------------|----------------------------------------|-------------------------------------|--------------------|
| Hemoglobin | 250 mg/dL | 47.2 mg/dL | -19 |
| Bilirubin (conjugated) | 6.25 mg/dL | 45.2 mg/dL | -27 |
| Bilirubin (unconjugated) | 25 mg/dL | 43.1 mg/dL | -2 |
| Lipemia (Triglycerides) | 1000 mg/dL | 44.3 mg/dL | +1 |

Gabriel J. Munaco Jr.

Andrews and

Gabriel J. Muraca, Jr. Manager Regulatory Affairs. .................................................................................................................................................. Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

7/6/99
Date

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Inorganic Phosphorus method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _

1. Intended Use

This in vitro diagnostic method is intended to measure Inorganic Phosphorus in luman serum, plasma or urine on the Bayer ADVIA IMS system. . Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1® Inorganic
Phosphorus	T01-1609-53	T03-1291-62

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IMS Inorganic
Phosphorus	B41-3734-46	T03-1291-62

A. Imprecision(SERUM)

ADVIA IMS
Level
(mg/dL)	Total CV(%)	L
(m
2.5	1.7
5.0	2.1
8.8	2.7

CHEM 1
Level
(mg/dL)	Total
CV(%)
3.1	3.4
6.6	2.7
7.7	2.8

B. Imprecision(URINE)

ADVIA IMS
Level
(mg/dL)	Total
CV(%)
24.8	1.9
69.8	2.2
96.3	1.9

CHEM 1
Level
(mg/dL)	Total
CV(%)
37	2.6
55	2.7

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	r	Sample Range (mg/dL)
Serum	CHEM 1+	50	Y = 0.94X + 0.15	0.15	0.997	1.3 - 10.0 mg/dL
Plasma(y), Serum(x)	ADVIA IMS	58	Y=0.96X-0.17	0.12	0.977	1.9-4.4 mg/dL
Urine	CHEM 1	48	Y = 1.01X + 0.15	1.17	0.999	4.5 - 99.9 mg/dL

Gabriel J. Menaca Jr. - Manager Reg. Affairs.
7/16/99

Interfering Substances

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Inorganic
Phosphorus
Conc. (mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|------------------------------------------|----------------------|
| Bilirubin | 20 | 3.7 | +2.2 |
| Hemoglobin | 500 | 3.6 | +19.4 |
| Lipids (Triglycerides) | 500 | 3.8 | +21.6 |
| Acetaminophen | 50 | 8.0 | -3.8 |
| Ascorbic Acid | 200 | 18.4 | +1.3 |
| Salicylate | 500 | 18.4 | +5.0 |

Analytical Range Serum/Plasma: Urine:

0 to 15 mg/dL 0 to 100 ing/dL

: : :

: 上一篇:

Gabriel J. Munoz Jr.
7/16/99

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Sodium,Potassium,and Chloride ISE methods for ADVIA® IMS I.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Intended Use

This in vitro diagnostic method to measure Sodium (Na), Potassium (K) and Chloride (CI) in human serum, plasma on the Bayer ADVIA IMS system

2. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IMS Sodium, Potassium,
Chloride	B48-4054-54	T21-4055-01 (Hi)
T21-4056-01 (Lo)

Imprecision

ANALYTE	Level (mmol/L)	Total CV(%)
Sodium	113	1.0
	139	1.0
Potassium	3.4	1.3
	5.9	1.2
Chloride	93	1.2
	113	1.2

Correlation (Y=ADVIA IMS, X=comparison system)

ANALYTE (Serum)	Comparison System (X)	N	Regression Equation	Syx (mmol/L)	R	Sample Range (mmol/L)
Sodium	IL Flame	53	$0.94 x Flame + 7.08 mmol/L$	1.68	0.957	120.0-147.1
Potassium	IL Flame	54	$1.03 x Flame - 0.15 mmol/L$	0.17	0.990	2.55-8.72
Chloride	Chloridometer	51	$0.84 x Chloridometer + 16.0 mmol/L$	1.1	0.986	83.6-115.5

Plasma/Serum Comparison

	Sodium	Potassium	Chloride
Mean Serum Level	137.2	3.97	105.2
Mean Plasma Level	137.2	3.76	105.2
Mean Difference	0.0	0.21	0.0
% Difference	0.0	5.6	0.0

Gabriel J. Muraca Jr.

G. J. Muraca Jr.

Manager RA Bayer Corporation

7/6/99

Date

ADVIA IMS ISE Na, K and Cl Report

Interfering Substances

Sodium: No significant effect on serum has been demonstrated from bromide, ammonium and iodide.

Potassium: Since the concentration of potassium inside erythrocytes is much greater than that in extracellular fluid, hemolysis should be avoided, and the serum/plasma should be separated from the cells as soon as possible after collection.

Chloride: Sodium Salicylate at a level of 2.2 mmol/L (30 mg/dL) will elevate the chloride result by less than 2.0 mmol/L. The presence of bromide or iodide salts will falsely elevate chloride results.

Analytical Range Serum or Plasma: Sodium 40 to 205 mmol/L Potassium 1.5 to 15 mmol/L 50 to 200 mmol/L Chloride

Gabriel J. Munoz, Jr.
7/16/99

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 5 1999

Mr. Gabriel J. Muraca, Jr. Manager. Regulatory Affairs Baver Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097

K992399 Re:

Trade Name: 9 Additional IMS Assays for the Bayer ADVIA® IMS™ System Regulatory Class: II Product Code: CIX, CIG, CHS, KXT, CHH, CEO JGS, CEM, CGZ Dated: July 16, 1999 Received: July 19, 1999

Dear Mr. Muraca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System (IMS)

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |

------------------------------------------	----	--------------------------------------------------

	(Division Sign-Off) Division of Clinical L 510(k) Number K992399
--	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Page 2 of 2

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System IMS

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)